Prospective follow-up study of subcutaneous tocilizumab (RoActemra®) treatment in rheumatoid arthritis.

Phase 4

Recruiting

• Conditions: rheumatic disease; rheumatoid arthritis; 10023213

• Registration Number: NL-OMON41073
• Lead Sponsor: Jan van Breemen Instituut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients:
- who are diagnosed with RA;
- in whom tocilizumab s.c. is prescribed by their treating rheumatologist; and
- who gave written informed consent.
Both bio-naive patients as patients who failed on previous biologic agents will be included.

Exclusion Criteria

Patients with contraindications for tocilizumab treatment. For patients previously treated with intravenous tocilizumab a washout period of 4 weeks is required.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- DAS28 score and response is defined as the EULAR criteria of a good or<br /><br>moderate response and a score of <3.2<br /><br>- Effect on RAPID-3/MDHAQ-2</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The number of adverse events (infections, malignancies, mortality)<br /><br>- ESR and/or CRP<br /><br>- The lipid profile<br /><br>- Inflammation processes<br /><br>- Relation between genetic polymorphisms and the efficacy of tocilizumab<br /><br>- Radiographic progression<br /><br>- Changes in bone mineral density<br /><br>- Cardiovascular risk factors</p><br>